Brentwood Instruments, Inc.
Mchenry, IL, US
Brentwood Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Brentwood Instruments, Inc. between 1981 and 1990. The busiest year on record is 1985, with 5. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 3 |
| 1985 | 5 |
| 1986 | 3 |
| 1988 | 2 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896924 | SPIROSCAN 4000 | BZG | Substantially Equivalent | |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | DSH | Substantially Equivalent | |
| K871572 | RHYTHMSCAN | DSI | Substantially Equivalent | |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | DSI | Substantially Equivalent | |
| K853979 | CARDIMAX FX-1164 | DPS | Substantially Equivalent | |
| K854505 | CARDIMAX FX-406U | DRS | Substantially Equivalent | |
| K851135 | SPIRO SCAN | BZG | Substantially Equivalent | |
| K851124 | T-1000 ECG TRANSMITTER | DXH | Substantially Equivalent | |
| K851123 | R-1000 ECG RECEIVER | DXH | Substantially Equivalent | |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | DSI | Substantially Equivalent | |
| K844470 | FUKUDA DENSHI MODEL FCP-220 | DPS | Substantially Equivalent | |
| K833594 | FUKUDA DENSHI FX-302 AUTO/THREE CHAN | DRT | Substantially Equivalent | |
| K833593 | FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN | DPS | Substantially Equivalent | |
| K842169 | FCP-11ECG | Unknown | ||
| K830907 | AMBULATORY ECG EVENT RECORDER | DSH | Substantially Equivalent | |
| K823586 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 | DSI | Substantially Equivalent | |
| K823585 | COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 | DSI | Substantially Equivalent | |
| K823584 | FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- | DPS | Substantially Equivalent | |
| K813021 | FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 | DPS | Substantially Equivalent | |
| K813023 | FUKUDA DENSHI CARDIMAX FK-11 | DSP | Substantially Equivalent | |
| K813022 | FUKUDA DENSHI CARDIMAX FK-12 | DPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DSHRecorder, Magnetic Tape, Medical
- BZGSpirometer, Diagnostic
- DSPSystem, Balloon, Intra-Aortic And Control
- DRSTransducer, Blood-Pressure, Extravascular
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Brentwood Instruments, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Brentwood Instruments, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain
